A Study to Evaluate the Effect of JNJ-53718678 on the Cardiac Repolarization Interval in Healthy Adult Participants

Janssen Research & Development, LLC52 enrolled

Overview

The purpose of this study is to assess the effect of JNJ-53718678 on QT interval corrected for heart rate (QTc) changes using exposure response analysis in healthy adult participants (Part 2).

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

DOUBLE

Enrollment

Conditions

Healthy

Interventions

JNJ-53718678, 2000 mgDRUG

Participants will be administered JNJ-53718678, 2000 mg as oral suspension in Part 1 (Panel 1).

JNJ-53718678, 3000 mgDRUG

Participants will be administered JNJ- 53718678, 3000 mg as oral suspension in Part 1 (Panel 2).

JNJ-53718678, 4500 mg or Dose to be decidedDRUG

Participants will be administered JNJ-53718678, 4500 mg as oral suspension in Part 1 (Panel 3). If this dose is considered safe and tolerable and if pharmacokinetic data require further dose escalation, then participants will receive JNJ-53718678 (Dose to be decided) in Part 1 (Panel 4). This dose (either from Panel 3 or Panel 4 ) will be used in Part 2 (Dose may be lower/higher based on review of safety, tolerability, and PK data obtained in Part 1).

Eligibility

Sex: ALLMin age: 18 YearsMax age: 55 YearsHealthy volunteers:

Medical Language ↔ Plain English

Inclusion Criteria: * Participants must have a Body mass index (BMI) between 18 and 30 kilogram per square meter (kg/m\^2) (inclusive), and body weight not less than (\<) 50 kg at screening * Participants must have a blood pressure between 90 and 140 millimeter of mercury (mmHg) systolic, inclusive, and no higher than 90 mmHg diastolic at screening * Participants must have a 12-lead electrocardiogram (ECG) consistent with normal cardiac conduction and function at screening, including: a) Normal sinus rhythm (heart rate (HR) between 45 and 100 beats per minute (bpm), inclusive); b) QT interval corrected for HR according to Fridericia's formula (QTcF) between 350 milliseconds (ms) and 430 ms for male participants, and between 350 ms and 450 ms for female participants (inclusive); c) QRS interval of ECG \<110 ms; d) PR interval of the ECG less-than or equal to (\<=) 200 ms; e) Morphology consistent with healthy cardiac conduction and function * A female participant must be of non-childbearing potential, defined as: a) Postmenopausal or b) Permanently sterile * A female participant must have a negative serum beta-human chorionic gonadotropin (b-hCG) pregnancy test at screening and a negative urine pregnancy test (except if postmenopausal) on Day -1 (or Day -2 in the first treatment period in Part 2) Exclusion Criteria: * Participants has a history of current clinically significant medical illness or certain laboratory abnormalities at screening * Participant has a history of hepatitis A virus immunoglobulin M (IgM) antibody, hepatitis B surface antigen (HBsAg), or hepatitis C virus (HCV) antibody positive, or other clinically active liver disease, or tests positive for hepatitis A virus IgM antibody, HBsAg or HCV antibody at screening * Participants with unusual T wave morphology (such as bifid T wave) likely to interfere with QTc measurements * Participants with a past history of heart arrhythmias or with a history of risk factors for Torsade de Pointes syndrome (for example, hypokalemia or family history of short/long QT syndrome, or sudden unexplained death at a young age \[\<=40 years\], drowning or sudden infant death in a first degree relative \[that is, sibling, offspring, or biological parent\]) * Participants with any skin condition likely to interfere with ECG electrode placement or adhesion

Locations (1)

Clinical Pharmacology Unit

Merksem, Belgium

Outcomes

Primary Outcomes

Part 2: Placebo-Corrected Change from Baseline in QT Interval Corrected for Heart Rate (QTc) for JNJ-53718678

Placebo-corrected change from baseline in QT interval corrected for heart rate (QTc) will be determined. The mean change from baseline in QTc in placebo treatment will be subtracted from the mean change from baseline in JNJ-53718678 treatment at the same time point to generate placebo-corrected change from baseline in QTc, which will be presented.

Time frame: Baseline and Day 1

Secondary Outcomes

Part 1: Number of Participants with Adverse Events as a Measure of Safety and Tolerability

An adverse event is any untoward medical event that occurs in a participant administered an investigational product, and it does not necessarily indicate only events with clear causal relationship with the relevant investigational product.

Time frame: Approximately up to 9 weeks

Part 2: Number of Participants with Adverse Events as a Measure of Safety and Tolerability

Time frame: Approximately up to 12 weeks

Part 1: Change from Baseline in QTc Interval

The QT interval corrected for heart rate (QTc interval) using Fridericia method will be measured by electrocardiograms (ECG).

Time frame: Baseline, 3, 24, 72 hours and at follow-up (10-14 days postdose)

Part 1: Change from Baseline in Heart Rate (HR)

The HR will be measured by ECG.

Time frame: Baseline, 3, 24, 72 hours and at follow-up (10-14 days postdose)

Data from ClinicalTrials.gov

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JNJ-53718678 500 mgDRUG

Participants will be administered JNJ-53718678, 500 mg as oral suspension in Part 2.

JNJ-53718678 PlaceboDRUG

Participants will be administered JNJ-53718678 matching placebo in Part 1 and 2.

Moxifloxacin 400 mgDRUG

Participants will be administered moxifloxacin 400 mg as capsule in Part 2.

Moxifloxacin PlaceboDRUG

Participants will be administered moxifloxacin matching placebo in Part 2.

Part 1: Change from Baseline in PR Interval

The PR Intervals will be measured by ECG.

Time frame: Baseline, 3, 24, 72 hours and at follow-up (10-14 days postdose)

Part 1: Change from Baseline in QRS Interval

The QRS Intervals will be measured by ECG.

Time frame: Baseline, 3, 24, 72 hours and at follow-up (10-14 days postdose)

Part 1: Percentage of Participants with T-Wave Morphology Changes from Baseline

Percentage of participants with T-wave morphology (Normal T-wave, Flat T-waves, Notched T-wave (positive), Biphasic, Normal T-wave (negative), Notched T-wave (negative) changes will be noted.

Time frame: Baseline up to 72 hours postdose

Part 1: Percentage of Participants with U-Wave Presence

Percentage of participants with U-wave presence will be noted.

Time frame: Baseline up to 72 hours postdose

Part 2: Change from Baseline in QTc Interval

The QT interval corrected for heart rate (QTc interval) using Fridericia method will be measured by ECG.